Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Nova Laboratories Ireland Limited, 3<sup>rd</sup> Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
Xaluprine 20 mg/ml oral suspension.
| Pharmaceutical Form |
|---|
|
Oral suspension. The suspension is pink to brown in colour. |
One ml of suspension contains 20 mg mercaptopurine (as monohydrate).
__Excipients with known effect:_ One ml of suspension contains 3 mg aspartame, 1 mg methyl hydroxybenzoate (as the sodium salt), 0.5 mg ethyl hydroxybenzoate (as the sodium salt) and sucrose (trace).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mercaptopurine |
Mercaptopurine is an inactive pro-drug which acts as a purine antagonist but requires cellular uptake and intracellular anabolism to thioguanine nucleotides for cytotoxicity. The mercaptopurine metabolites inhibit de novo purine synthesis and purine nucleotide interconversions. The thioguanine nucleotides are also incorporated into nucleic acids and this contributes to the cytotoxic effects of the active substance. |
| List of Excipients |
|---|
|
Xanthan gum |
Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 100 ml of oral suspension.
Each pack contains one bottle, an HDPE bottle adaptor and 2 polyethylene dosing syringes (a purple syringe graduated to 1 ml and a white syringe graduated to 5 ml).
Nova Laboratories Ireland Limited, 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
EU/1/11/727/001
Date of first authorisation: 09 March 2012
Date of latest renewal: 18 November 2016
| Drug | Countries | |
|---|---|---|
| XALUPRINE | Austria, Estonia, Finland, France, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom |
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